Kornimate/medical-research-clean huggingface dataset:
evaluate impact of exercise program on fatigue in breast cancer during chemotherapy

Conditions: Breast Cancer

Summary: assess feasibility of home exercise in reducing fatigue in subjects with breast cancer receiving curative intent chemotherapy. subjects are randomized to control (no exercise) or intervention group (exercise). the pro-ctcae tool and facit fatigue scale are used to collect patient reported outcomes. subjects submit data via mobile phone, tablet or computer. assessments are weekly during chemotherapy (10-20 wks), at end of chemotherapy and 1, 3 and 6 months after chemotherapy.

the goal of this project is to determine the feasibility of a specific home-based exercise intervention in reducing cancer-related fatigue (crf) in breast cancer patients undergoing curative-intent chemotherapy. the outcome will be measured by using the facit fatigue scale, administered by using the carevive prompt® platform. primary objectives: 1. . to examine the feasibility of recruitment and retention of women undergoing treatment for breast cancer over the duration of the chemotherapy regimen. 2. to examine the adherence to the exercise regime for those in the intervention group and compare the retention rates between treatment and control groups 3. to compute the means and standard deviations (sd) of the facit responses over time in both groups for use in future power analyses to aid in the design of a futre hypothesis testing rct. secondary objectives: 1. to quantify the change over time in pro-ctcae derived symptoms and other pros by computing means and sd. 2. to test for group differences in the trajectory of change over time in fact using a mixed model repeated analysis

Eligibility criteria:
inclusion criteria: * women with curative-intent breast cancer who plan to undergo at least 4 cycles of chemotherapy. * age \> 18 years * ecog performance score \< 3 * english-speaking * with sufficient vision/hearing or family support * coronary artery disease, if cleared by cardiologist * subject must have smart phone, computer or tablet. * willingness to be randomized exclusion criteria: * medical or psychiatric conditions (beyond those related to breast cancer and its treatment) that would impair our ability to test study hypotheses (psychotic disorders, dementia, inability to give informed consent or follow instructions). * patients with overt evidence of a psychiatric disorder. * coronary artery disease, not cleared by cardiologist. * contraindication to exercise. * chronic fatigue syndrome.
metabolomic profiling of novel mediators of vascular function

Conditions: Type 2 Diabetes Mellitus

Summary: the purpose of this study is to identify and characterize specific chemicals and metabolic pathways that change with forearm ischemia. these changes will be compared with forearm blood flow and flow-mediated vasodilation of the brachial artery.


Eligibility criteria:
inclusion criteria: * adults age 18 or older * type 2 diabetes mellitus exclusion criteria: * type 1 diabetes mellitus * type 2 diabetics taking insulin, thiazolidinediones (rosiglitazone or pioglitazone), an amylin analog (symlin \[pramlintide\]), or incretin mimetics (byetta \[exenatide\]) * pregnancy * uncontrolled hypertension, \> 180/100 mmhg

Keywords: metabolomics flow-mediated vasodilation
comparison of vonoprazan-based dual and triple therapies for h. pylori eradication

Conditions: Gastritis Associated With Helicobacter Pylori

Summary: patients infected with h. pylori were randomly assigned to the dual therapy with vonoprazan 20 mg bid and amoxicillin 500 mg tid for 1 week or the triple therapy with vonoprazan 20 mg bid, amoxicillin 750 mg bid and clarithromycin 200 mg or metronidazole 250 mg bid bid for 1 week. success or failure of eradication was determined by the 13c-urea breath test performed at 1 month after the therapy.

patients infected with h. pylori were enrolled and invited to the study. patients who have never undergone the h. pylori eradication therapy are randomly assigned to the dual therapy with vonoprazan 20 mg bid and amoxicillin 500 mg tid for 1 week or the triple therapy with vonoprazan 20 mg bid, amoxicillin 750 mg bid and clarithromycin 200 mg bid for 1 week. patients who have ever failed in the eradication of h. pylori by the triple therapy containing clarithromycin are randomly assigned to the dual therapy with vonoprazan 20 mg bid and amoxicillin 500 mg tid for 1 week or the triple therapy with vonoprazan 20 mg bid, amoxicillin 750 mg bid and metronidazole 250 mg bid for 1 week. success or failure of eradication was determined by the 13c-urea breath test performed at 1 month after the therapy.

Eligibility criteria:
inclusion criteria: * patients infected with h. pylori * patients who are not allergic to any of drugs used in this study * patients who agree to participate to the study patients who are treatment naive for eradication of h. pylori exclusion criteria: * patients not infected with h. pylori * patients who are allergic to any of drugs used in this study * patients who do not agree to participate to the study * severe general condition, such as renal insufficiency or liver dysfunction * history of gastrectomy * inability to undergo eradication therapy * patients who have ever undergone the eradication therapy for h. pylori infection

Keywords: pylori
a study of efficacy and safety of combination therapy with guselkumab and golimumab in participants with moderately to severely active ulcerative colitis

Conditions: Colitis, Ulcerative

Summary: the purpose of this study is to evaluate the clinical efficacy and safety of combination therapy with guselkumab and golimumab in participants with moderately to severely active ulcerative colitis (uc).


Eligibility criteria:
inclusion criteria: * confirmed clinical diagnosis of ulcerative colitis (uc) at least 3 months before screening * moderately to severely active uc as defined by mayo score * history of inadequate response to or failure to tolerate conventional therapy * has screening laboratory test results within the study protocol defined parameters * a woman of childbearing potential must have a negative highly sensitive serum (beta human chorionic gonadotropin) pregnancy test result at screening and a negative urine pregnancy test result at week 0 exclusion criteria: * has severe extensive colitis as defined in the study protocol * has uc limited to the rectum only or to less than (\<) 20 centimeter (cm) of the colon * has a history of latent or active granulomatous infection, including histoplasmosis or coccidioidomycosis, before screening * has any known malignancy or has a history of malignancy (with the exception of basal cell carcinoma; squamous cell carcinoma in situ of the skin; or cervical carcinoma in situ that has been treated with no evidence of recurrence; or squamous cell carcinoma of the skin that has been treated with no evidence of recurrence within 5 years before screening) * has known allergies, hypersensitivity, or intolerance to guselkumab or golimumab or their excipients
evaluation of the metaneb® system to reduce postoperative pulmonary complications

Conditions: Atelectasis; Pulmonary Complications

Summary: to determine if a therapy regimen including treatment with the metaneb® system had a positive impact on the rate of pulmonary complications related to atelectasis and/or secretion retention that occur in high risk post-operative patients. this is a non-randomized facility (or hospital) level pre-post intervention study.

post-operative pulmonary complications (ppc) are associated with significant excess morbidity, mortality and healthcare expenditure. although ppcs are an incompletely understood multifactorial syndrome, atelectasis is recognized as a critical component. a variety of strategies have been shown to reduce the risk for development of post-operative atelectasis including lung expansion (le) therapies. well-designed studies are needed to distinguish which le approach has the greatest potential to optimize patient care, clinical outcomes and cost savings. intrapulmonary percussive ventilation (ipv) devices have been in use for more than 25 years and are used widely in the acute care, post-surgical, and homecare setting. such devices provide both le and airway clearance therapy (act) for patients with obstructive and/or restrictive lung diseases and conditions. the metaneb® system is an le expansion modality that incorporates all the physiological effects of ipv while providing additional therapeutic advantages intended primarily to more effectively treat or prevent pulmonary atelectasis. the study was be conducted in two stages. in stage i of the study, a retrospective review of medical records for post-surgical patients, who received standard therapy as defined by current hospital and respiratory care department policies and procedures was performed. in stage ii, a change in practice was made and patients received standard care with the addition of therapy with the metaneb® system. demographic, clinical \& outcome data was collected for eligible patients during the two stages of the study. study staff collected data from the medical records, following a protocol determined schedule.

Eligibility criteria:
inclusion criteria: age ≥ 18 years post-thoracic, -upper abdominal or -aortic surgery open surgical procedure incision at or above the umbilicus high risk defined by: documented asa class ≥ 3 or documented asa class 2 and one or more of the following: current smoker or smoking history within past 6 months history of copd documented obesity and/or bmi ≥ 30 kg/m2 age ≥ 75 exclusion criteria: contraindication to continuous high frequency oscillation (chfo) therapy minimally invasive, or ". . . scopic" procedure. spinal surgery involving a posterior approach. surgery for organ transplant. chronic invasive positive pressure ventilation (ppv)
biomarker evaluation in advanced stage cervical cancer by an international working group. tumor stages (1b1 - 4)

Conditions: Cervical Cancer

Summary: prospective multicentric european trial for cervical cancer, not previously treated, with tumour biopsies, and blood collection for molecular analysis at predetermined time points.


Eligibility criteria:
inclusion criteria: 1. no prior treatment for cervical cancer. 2. figo stage ib1 to ivb; all histological subtypes (excluding neuro-endocrine type). 3. pelvic mri available or planned before the start of treatment, , if figo ≥ ib2. and optional for ib1 stage 4. possibility to communicate imaging data by cd-rom (format dicom 3.0 or more). 5. disease amenable to biopsy (3 tumour samples are mandatory prior to treatment). 6. age ≥ 18 years. 7. ecog (eastern cooperative oncology group) 0-2. 8. life expectancy \> 6 months. 9. patient eligible for standard treatment (according to standards of each center). 10. patient having health care insurance. 11. informed and signed consent by patient. (dicom = digital imaging and communications in medicine) exclusion criteria: 1. patient enrolled in a clinical trial involving an investigative new agent. 2. co morbidity, preventing patient to tolerate the proposed standard treatment. 3. past history of invasive cancer over the 5 years preceding entry in the present trial (except basal cell carcinoma and carcinoma in situ of the cervix). 4. impossibility to carry out evaluation by mri (patient claustrophobic, pacemaker, metallic implant, non availability, other), ), if figo ≥ ib2 . 5. patient deprived from ability to decide on her own. 6. patient unable to have a regular follow up for geographical, social or psychological reasons. 7. pregnancy or patient old enough to procreate and not using effective contraceptive method.

Keywords: cervical cancer tumor biopsies standard treatment molecular profile next generation sequencing
endometrial scratching for cryopreserved embryo transfer

Conditions: Subfertility

Summary: endometrial injury performed in a cycle preceding the one for embryo transfer is associated with an increased implantation and pregnancy rate when carried out during the month preceding that of ovulation induction and fresh embryo transfer. however, there is no evidence about the effect of this intervention on the transfer of cryopreserved embryos.


Eligibility criteria:
inclusion criteria: * age \> 18 * at least one cryopreserved embryo exclusion criteria: * none
pkp2-acm natural history study

Conditions: Cardiomyopathies; Heart Diseases; Cardiovascular Diseases; Genetic Diseases

Summary: the goal of this study is to describe the natural history and clinical events for patients who have arrhythmogenic cardiomyopathy with pathogenic plakophilin-2 variants (pkp2-acm) managed with standard of care.

this is an observational study with both retrospective and prospective data collection. the study is designed to describe the natural history of pkp2-acm including the signs and symptoms, key clinical events, and impact of the disease on quality of life. a hybrid (retrospective and prospective data collection) approach is being taken with the aim of achieving robust and longitudinal data generation.

Eligibility criteria:
inclusion criteria patients must meet all the following criteria (and none of the exclusion criteria) to be eligible for study participation: 1. male or female age 12 years or older at the time of providing informed consent (i.e., icf provision). 2. capable and willing to provide signed informed consent and/or assent, which includes compliance with the requirements and restrictions listed in the icf and protocol. 3. clinical diagnosis of arrhythmogenic cardio myopathy (acm) as defined by the 2010 revised task force criteria (tfc) 4. documentation of a pathogenic or likely pathogenic variant in pkp2 by a clia-certified genetic testing laboratory 5. history of icd implantation ≥6 months prior to icf provision 6. left ventricular ejection fraction by echocardiogram or cardiac magnetic resonance (cmr) ≥50% at ≤12 months prior to icf provision exclusion criteria patients meeting any of the following criteria are excluded from study participation: 1. gene testing indicates that the subject's arrhythmia or cardiomyopathy may be related to a genetic etiology other than pkp2 truncating variant. 2. concurrent participation in any other clinical investigation involving use of an investigational agent that could confound results of this study. 3. previous participation in a study of gene transfer or gene editing. 4. nyha class iv heart failure. 5. presence or requirement for mechanical circulatory support (mcs) or predicted need for mcs or heart transplantation within 6 months of enrollment. 6. prior cardiac or other organ (lung, liver, other) transplantation. 7. pacemaker dependent rhythm documented, as assessed by the principal investigator ≤12 months prior to enrollment. 8. positive human immunodeficiency virus (hiv) antibody test. 9. unwillingness to comply with study procedures, including follow-up as specified by this protocol, or unwillingness to fully cooperate with the investigator.

Keywords: arrhythmogenic cardiomyopathy plakophilin-2 arrhythmogenic cardiomyopathy (ac, arvd/c) pkp2
cbt texts for ptsd & hazardous drinking (project better)

Conditions: Posttraumatic Stress Disorder; Alcohol Use

Summary: the research study seeks to refine and test a brief, self-directed, intervention for individuals from the general public with ptsd and co-occurring hd that can be delivered via text-messaging. this application seeks to refine the intervention further by testing whether theoretically-driven, evidence-based strategies from basic cognitive psychology (message framing) and social psychology (facilitating growth mindsets) result in better outcomes for ptsd symptoms and hd by addressing pilot participant feedback related to avoidance and motivation.

this study will refine a previously piloted text message intervention by integrating and testing the efficacy of behavioral nudge and psychologically-wise intervention techniques when added to cbt text messages for reducing hazardous drinking (hd) and ptsd symptoms.the enhancements will be tested in a fully crossed 3 (message framing: avoid losses vs. maximize gains vs. no framing) x 2 (mindsets: facilitate growth mindset reminder vs. simple reminder to use skills) factorial design to identify the most effective combination of text messages. a sample of 500 participants with dsm-5 criterion a trauma exposure, ptsd symptoms, and hd will be enrolled and randomized to condition. baseline, immediate post-, 1-, and 3-month assessments will capture change in primary outcomes (ptsd, hazardous drinking). trauma exposure and ptsd symptoms will be assessed using the posttraumatic stress disorder checklist, civilian version dsm-5 with the life events checklist (pcl-5 and lec). hd will be assessed via a set of measures that provide a detailed picture of drinking patterns. first, two questions will ask about heavy episodic drinking (hed: 4/5 or more drinks per single occasion for men/women) episodes, assessing both frequency over the lifetime and frequency over the last month. typical weekly alcohol consumption will also be assessed using the daily drinking questionnaire (ddq). negative alcohol-related consequences will be assessed via the short index of problems (sip).

Eligibility criteria:
inclusion criteria: 1. 18+ years of age 2. currently resides in wa state 3. fluent in english 4. reports at least one dsm-5 traumatic event that occurred 1+ months ago 5. current ptsd severity of 33+ on the pcl-5 6. current hazardous alcohol use (2+ heavy episodic drinking occasions \[4+ drinks on one occasion for women, 5+ drinks on one occasion for men\] in past month, 1+ negative consequences related to alcohol use) 7. owns a functioning cellular phone 8. is willing to receive weekly study text messages for 4 consecutive weeks 9. is willing to provide contact information including phone number (for text messages and reminders), email (reminders), and mailing address (payment) exclusion criteria: -

Keywords: hazardous drinking posttraumatic stress disorder
study of food preferences and sensory perceptions after bariatric surgery

Conditions: Obesity

Summary: several studies report changes in food preferences in favor of low energy density foods after bariatric surgery and changes in scores of liking and desire to eat, as well as changes in hedonic evaluation certain foods. however, only one study was held in a more realistic condition of consumption by using real food, looking at some aspects of food preferences and giving contradictory results. we hypothesise that food preferences are different between obese people with and without a bariatric surgery. the main objective of this study is to compare the differences in food quality (proportion of total energy intake from foods with high energy density versus foods with low energy density), evaluated during a standardized and validated buffet between adult women with severe complicated or morbid obesity and women who have undergone bariatric surgery in the last 12 months.


Eligibility criteria:
inclusion criteria: * woman from 18 to 65 years old (included) * person capable of going to the institut paul bocuse research center, bellecour platform, 20 place bellecour, 69002 lyon * person who agree to participate in the study * person having signed the consent of image rights * for the surgery group: person who has undergone bariatric surgery (except gastric band) * for the control group: person with a bmi ≥ 35 kg / m2 who did not benefit from bariatric surgery exclusion criteria: * person with a food allergy or food intolerance to at least one of the study products * person excluding certain foods from their diet for religious or personal reasons. * person who smoke * person with severe digestive disorders, dysphagia, abdominal pain * person who cannot give her agreement, not mastering the french language * person who has exceeded the annual amount of compensation in the year for participation in research protocols * pregnant or breastfeeding woman or not taking effective contraception * person with a history of pathology which may interfere according to the investigator with the criteria of the study (ent, neurological, upper digestive pathologies, ...) * for the surgery group: conversion of any type of bariatric surgery
analysis of risk factors associated with the development of toxic encephalopathy in acute diquat poisoning

Conditions: Poisoning; Toxic Encephalopathy

Summary: this study aims to analyze the risk factors associated with the development of toxic encephalopathy in acute diquat poisoning.


Eligibility criteria:
inclusion criteria: 1. history of oral exposure to dq solution reported by patient or proxy; 2. a specimen for the dq plasma concentration collected immediately upon admission; 3. documentation that patients or, in case of unconsciousness of the patient, legal proxies were aware of and agreed to treatment plans. exclusion critera: 1. they had ingested other toxicants in addition to dq; 2. dq was not detected in biological samples; 3. patients with over half of incomplete information; 4. patients with an exposure time (time from exposure to presentation at ed) longer than 48 hours.
development of an active video-based high-intensity interval exercise system in children with asthma

Conditions: Asthma in Children

Summary: the aim of the study was to develop an active video-based high-intensity interval exercise system for the rehabilitation programs of children with asthma and to compare its immediate effects on heart rate variability, hemodynamic responses and thermal responses with a conventional high-intensity interval exercise.

the research consists of two main stages. for the first stage, an active video-based high-intensity interval exercise system will be developed. the game to be developed is considered as an entertaining supporter that adjusts the exercise intensity with the data by the heart rate sensor, warns with visual cues when the child needs to increase the exercise intensity, and keeps the child engaged in the exercise. the second stage is planned to compare the exercise system with the conventional high-intensity interval exercise method that has the same features. the patient follow-up process will be monitored as; the patient who meets the inclusion and exclusion criteria will be directed by the physician, the patient and family consent will be obtained, pre-intervention evaluation, randomization, intervention, and post-intervention evaluation. the entire process will be carried out in one day. the patients will be randomized into two groups: conventional high-intensity interval exercise and game-based high-intensity interval exercise, before the evaluation with the closed envelope method. exercise will be applied at equal intensity (85% of the maximum heart rate) and duration for both groups, and the heart rate of the game-based group will be monitored with the sensor integrated into the game.

Eligibility criteria:
inclusion criteria: * having asthma diagnosis according to gina criteria * being between 8-15 years of age * having stabil asthma * coming to routine follow-ups regularly * being under regular pharmacological treatment and having good compliance with treatment confirmed by a physician * volunteering to participate in the study (both child and parent) exclusion criteria: * having another diagnosed chronic disease other than asthma * obesity (body mass index over 25 * not having stable asthma defined as having had an exacerbation in the last 4 weeks * having severe persistent asthma * having exercise-induced asthma * not being able to complete the exercise capacity test * not being able to maintain the intensity of exercise ±5%

Keywords: high intensity interval training video-based exercise asthmatic children immediate response